Whole green coffee bean products and methods of production and use for focus and concentration

ABSTRACT

Disclosed are novel processing methods for green coffee beans that result in novel green coffee bean products, including products that incorporate whole green coffee beans. Methods include selecting whole coffee beans in their fresh green unroasted state with naturally-occurring levels of phytonutrients, sterilizing and drying them, applying iterative grinding processes and stabilization techniques, all while avoiding high temperatures. Whole green coffee bean products created and defined by these methods have unexpectedly been found to increase focus and concentration in users, and are believed useful in the treatment of attention and concentration deficits and related disorders, such as attention deficit (AD), attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD), and various related and/or comorbid disorders.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation-in-Part of U.S. patent applicationSer. No. 13/215,174 filed on Aug. 23, 2011, which issued as U.S. Pat.No. 9,034,410, which claims priority to PCT application No.PCT/US12/51585 filed on Aug. 20, 2012, the contents of which are bothhereby incorporated in their entirety.

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BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to methods of processing green coffeebeans, products obtained and defined by those methods, and methods oftreatment using those products.

2. Description of the Related Art

The term “coffee bean” collectively refers to the seeds (coffee seeds)that are obtained by the refining process of removing the pulp and theskin from the berries (known as coffee berries or coffee cherries) ofCoffea plants, and the beans that are produced from these. Coffeeberries, which contain the coffee bean, are produced by several speciesof small evergreen plants of the genus Coffea, which are of the familyRubiaceae. The two most commonly grown species are Coffea robusta (alsoknown as Coffea canephora) and Coffea arabica. These are typicallycultivated in Latin America, Southeast Asia, and Africa. “Green” coffeebeans are coffee beans that have not yet passed through a roastingprocess, such as the roasting process used in the production of coffee.

The various steps in the production of coffee are described in Smith, A.W., in Coffee; Volume 1: Chemistry pp 1-41, Clark, R. J. and Macrea, R.eds, Elsevier Applied Science London and New York, 1985; Clarke, R. J.,in Coffee: Botany, Biochemistry, and Production of Beans and Beverage,pp 230-250 and pp 375-393; and Clifford, M. N. and Willson, K. C. eds,Croom Helm Ltd, London, as described in U.S. patent application Ser. No.12/941,557 titled Modulation Of Coffee Flavour Precursor Levels In GreenCoffee Grains, filed Nov. 8, 2010 on behalf of McCarthy, et al., andpublished on May 26, 2011 as publication number U.S. 2011/0126314 A1(hereafter “McCarthy”), the entirety of which is incorporated herein byreference as though set forth in full herein. The process typicallystarts with the collection of mature, ripe red coffee cherries. Theouter layer, or pericarp, can then be removed using either the dry orwet process. The dry process is the simplest and involves: (1)classification and washing of the cherries; (2) drying the cherriesafter grading (either air drying or mechanical drying); and (3)dehusking the dried cherries to remove the dried pericarp. The wetprocess is slightly more complicated, and generally leads to theproduction of higher quality green beans. The wet process is more oftenassociated with C. arabica cherries. The wet process may comprise: (A)classification of the cherries; (B) pulping of the cherries (this stepis done soon after harvest and generally involves mechanical removal ofthe “pulp”, or pericarp, of the mature cherries); (C) “fermentation,”where the mucilage that remains attached to the grain of the cherriesafter pulping is removed by allowing the grain plus attached mucilage tobe incubated with water in tanks using a batch process. The“fermentation” process is allowed to continue up to 80 hours, althoughoften 24 hours is generally enough to allow an acceptable fermentationand to cause the pH to drop from around 6.8-6.9 to 4.2-4.6, due tovarious enzymatic activities and the metabolic action of microorganismswhich grow during the fermentation. The next steps, (D) drying, involveseither air or mechanical hot air drying of the fermented coffee grain,and (E) “hulling,” involves the mechanical removal of the “parch” of thedried coffee grain (dried parchment coffee) and often the silverskin.After wet or dry processing, the resulting green coffee grain are oftensorted, with most sorting procedures being based on grain size and/orshape.

The next step in the production of conventional coffee is the roastingof the green grain after dehusking or dehulling of dry or wet processedcoffee, respectively. This is a time-dependent process which inducessignificant chemical changes in the bean. The first phase of roastingoccurs when the supplied heat drives out the remaining water in thegrain. When the bulk of the water is gone, roasting proper starts as thetemperature rises towards 374-392 degrees Fahrenheit. The degree ofroasting, which is usually monitored by the color development of thebeans, plays a major role in determining the flavor characteristics ofthe final beverage product. Thus, the time and temperature of theroasting are tightly controlled in order to achieve the desired coffeeflavor profile. After roasting, the coffee is ground to facilitateextraction during the production of the coffee beverage or coffeeextracts (the latter to be used to produce instant coffee products).Again, the type of grinding can influence the final characteristics ofthe product, such as the flavor of the beverage.

While a considerable amount of research has been carried out on theidentification of the flavor molecules in coffee, much less work hasbeen done regarding the physical and chemical reactions that occurwithin the coffee grains during each of the processing steps. Thislatter point is particularly evident for the roasting reaction, wherethe large number of grain constituents undergo an extremely complexseries of heat induced reactions (Homma, S. 2001, In “Coffee: RecentDevelopments”. R. J. Clarke and O. G. Vitzthum eds, Blackwell Science,London; Yeretzian, C., et al ((2002) Eur. Food Res. Technol. 214,92-104; Flament, I (2002) Coffee Flavor Chemistry, John Wiley and Sons,UK; Reineccius, G. A., “The Maillard Reaction and Coffee Flavor”Conference Proceedings of ASIC, 16th Colloque, Kyoto, Japan 1995).

While the details of most of the reactions that occur during thedifferent steps of coffee processing remain relatively unclear, it isunderstood that the conventional roasting process likely destroys ordegrades many beneficial components present in green coffee beans,including phytonutrients such as, for example, Chlorogenic acid.Chlorogenic acids (CGA) are a family of esters formed between certainhydroxycinnamic acids (i.e. caffeic and feluric acids) and (−)-quinicacid. Green (or raw) coffee is a major source of CGA in nature (5-12g/100 g) (Farah et al. Braz J Plant Physiol. 365 2006; 18:23-36). Themajor CGA in green coffee are 3-, 4- and 5-caffeoylquinic acids (3-, 4-and 5-CQA), 3,4-, 3,5- and 4,5-dicaffeoylquinic acids (3,4-, 3,5-, and4,5-diCQA); 3-, 4- and 5-feruloylquinic acids (3-, 4- and 5-FQA) and 3-,4- and 5-p-coumaroylqunic acids (3-, 4-, and 5-p-CoQA).Caffeoylferuloylquinic acids (CFQA) are minor CGA compounds also foundin green coffee, especially in Coffea robusta species, as described inU.S. patent application Ser. No. 263292 titled Effects Of ADecaffeinated Green Coffee Extract On Body Weight Control By RegulationOf Glucose Metabolism, filed Oct. 31, 2008 on behalf of Lemaire, et al.,and published on May 6, 2010 as publication number U.S. 2010/0112098 A1(hereafter “Lemaire”), the entirety of which is incorporated herein byreference as though set forth in full herein. Very small amounts of CGAlactones formed by heating during primary processing may also beobserved (Farah et al. Braz J Plant Physiol. 2006, 18:23-36.—Farah etal. J Agric Food Chem. 2005; 53:1505-13).

While green coffee beans have recently been recognized to have somepotentially important health benefits (see, e.g., Lemaire, above),products created from green coffee beans have not been widely availablelike roasted coffee. Part of the reason for this is that processing,preserving and packaging coffee beans in their nutritious, unroasted,“green” state has been difficult, expensive and generally not feasible.For example, Lemaire teaches only extracting certain substances from thegreen coffee bean, not processing of the entire green coffee bean.

Accordingly, what is needed is an improved method of processing greencoffee beans, including partial or whole green coffee beans, that can beused to more easily and inexpensively create green coffee bean products,such as capsules, tablets, mixes, additives, supplements, and the like.Such an improved method is needed to unlock the potential healthbenefits to consumers of relatively inexpensive products created withgreen coffee beans, especially whole green coffee beans.

In addition, individuals progressing through academic study requireconcerted focused attention in order to successfully master the tasksposed by school. Control of attention is managed by executive functionsthat help to prioritize, organize, and complete work in a timely way.Russell Barkley describes executive functions as the actions people useto control personal behavior, direct behavior toward a goal, and improveoutcomes for behavior in the future. The role of attention in executivefunctions is critical in most facets of organized daily life.

Attention wandering compromises executive functions and results incognitive difficulties in learning. Attention problems are certainlyevident, for example, in attention-deficit/hyperactivity disorder (ADHD)which is a developmental disorder in children, and, to varying degreesin adults. The etiology and impact of poor attention is multifactorialand impacts school performance of children, adolescents, and youngadults.

Alternative and complementary treatments may be helpful in managingbehaviors associated with attention to school tasks, thus it is usefulto investigate them.

Worldwide, caffeine is the most widely consumed substance havingpsychoactive effects. It is the neuroactive agent in coffee and tea, andit is a nonselective antagonist of the neuromodulator adenosine; ifapplied in commonly consumed doses, it generates stimulating effects byblockading adenosine receptors. Cognitive performance generally ispositively influenced by caffeine ingestion, and the influence ofcaffeine on cognitive performance is well documented. Although somestudies show limited benefit to performance, caffeinated coffee is themost common form of caffeine intake, increasing alertness and loweringfatigue. Caffeine is now readily available in a variety of liquid (ie,energy drinks) and capsule forms.

BRIEF SUMMARY OF THE INVENTION

Disclosed are novel processing methods for green coffee beans thatresult in novel green coffee bean products, including products thatincorporate whole green coffee beans. Green coffee bean products createdand defined by these methods have unexpectedly been found to increasefocus and concentration in users, and are believed useful in thetreatment of attention deficits. Accordingly, provided herein are novelmethods of treatment using green coffee beans and related productscomprising whole green coffee beans to increase focus and concentrationin users, and to treat attention and concentration deficits and relateddisorders, such as attention deficit (AD), attention deficit disorder(ADD), attention deficit hyperactivity disorder (ADHD), and variousrelated and/or comorbid disorders.

More specifically, provided in certain embodiments is a method ofprocessing whole green coffee beans to create stabilized whole greencoffee bean mixtures, that includes the steps of: selecting whole coffeebeans in their fresh green unroasted state with naturally-occurringlevels of phytonutrients; sterilizing the coffee beans; reducing themoisture content of the coffee beans; grinding the coffee beans; andmixing at least one stabilizer into the ground coffee beans; wherein allof the aforesaid steps are accomplished without exposing the coffeebeans to high enough temperatures for a sufficient amount of time tosubstantially degrade the naturally-occurring levels of phytonutrientsin the coffee beans. In certain embodiments, all of the aforesaid stepsare accomplished without exposing the coffee beans to temperaturesexceeding about 130 degrees Fahrenheit for more than a few seconds. Thewhole green coffee beans may comprise Coffea robusta coffee beans, andthe phytonutrients may include Chlorogenic acid, including in someembodiments at least two percent by weight of Chlorogenic acid. The stepof reducing the moisture content of the coffee beans may comprisereducing the moisture content of the coffee beans to less than about twopercent. The at least one stabilizer may comprises at least one of, orall of, Magnesium Silicate; Silicon Dioxide; Tricalcium Phosphate.

In various embodiments, the step of grinding the coffee beans maycomprise a plurality of iteratively finer grinding steps, such as threeincreasingly fine steps. For example, the step of grinding the coffeebeans may result in most of the ground coffee bean material being sizedto pass through a 20 mesh screen.

Also provided are stabilized whole green coffee bean mixtures thatnecessarily results from and is defined by the foregoing processes. Thestabilized whole green coffee bean mixtures may be packaged into atleast one of the following forms: packaged in bulk powder form;compressed into a tablet; inserted into a capsule; or mixed with anothernutritional supplement or product.

A method is also provided that increases the concentration of andfocuses the attention of a user, that includes the step of administeringan amount of stabilized whole green coffee bean mixture effective totreat the user.

These and other objects and advantages of the present invention willbecome apparent from a reading of the attached specification andappended claims. There has thus been outlined, rather broadly, the moreimportant features of the invention in order that the detaileddescription thereof that follows may be better understood, and in orderthat the present contribution to the art may be better appreciated.There are features of the invention that will be described hereinafterand which will form the subject matter of the claims appended hereto.

BRIEF DESCRIPTION OF THE DRAWINGS

Further features, advantages and characteristics of the presentinvention will become apparent to a person of ordinary skill in the artin view of the following detailed discussion of example embodiments ofthe present invention, made with reference to the drawings annexed, inwhich:

FIG. 1 provides a flow chart showing example steps of a method forprocessing whole green coffee beans and generating resulting whole greencoffee bean products;

FIG. 2 provides a flow chart showing example sterilization steps of amethod for processing whole green coffee beans and generating resultingwhole green coffee bean products;

FIG. 3 provides a flow chart showing example sizing steps of a methodfor processing whole green coffee beans and generating resulting wholegreen coffee bean products;

FIG. 4 provides a flow chart showing example steps of a method forstabilizing whole green coffee beans and generating resulting wholegreen coffee bean products;

FIG. 5 provides a flow chart showing example steps of a method fortesting whole green coffee beans and generating resulting whole greencoffee bean products; and

FIG. 6 provides a flow chart showing example steps of a method forpackaging whole green coffee beans and generating resulting whole greencoffee bean products;

FIGS. 7-32 are graphs from studies showing levels of chlorogenic acid inhumans at extended periods of time.

DETAILED DESCRIPTION

Before explaining at least one embodiment of the invention in detail, itis to be understood that the invention is not limited in its applicationto the details of construction and to the arrangements of the componentsset forth in the following description or illustrated in the drawings.The invention is capable of other embodiments and of being practiced andcarried out in various ways. Also, it is to be understood that thephraseology and terminology employed herein are for the purpose ofdescription and should not be regarded as limiting.

FIG. 1 shows a process 1000 for preparing whole or partial green coffeebeans for tableting, encapsulation, and or other nutritional uses suchas mixes, additives, supplements, and the like. Process 1000 has beendeveloped to tend to preserve the Chlorogenic Acid and otherphytonutrient content of the green coffee beans by using relatively lowtemperatures, for instance in one example not more than about 130degrees Fahrenheit, throughout the processing steps.

Step 1—Berry Selection:

The first step in process 1000 is berry selection 100. Whole coffeebeans are selected in their fresh green unroasted state, preferably withhigh levels of Chlorogenic Acid and other naturally occurringphytonutrients. For example, the Coffea robusta species of berries maybe selected. However, any suitable berry or combination of berries maybe selected.

Step 2—Sterilization:

Turning to FIG. 2, in the second step, sterilization 200, the processingmachinery must be sterilized. The machinery, such as a ribbon mixer,should be sanitized to make certain that it is clean and free from anydebris from products that were processed prior to green coffee. Themachinery may also be cleaned with an industrial strength sanitizingsolution that kills microbial contamination. In one embodiment, themachinery comprises a Weiler & Company Model 1660 thirty cubic footribbon mixer that may be cleaned in a three-step process. In step one,the detergent phase 210, the mixer may be cleaned with trisodiumphosphate or similar substance to remove any filth or debris. In steptwo, clear water rinse 220, the mixer is rinsed thoroughly with cleanpotable water to remove any detergent residue. Then in step three, thesanitizing phase 230, all food contact surfaces may be saturated withalcohol or other appropriate organic solvent, such as a 70% isopropylalcohol (IPA) solution, and allowed to air dry.

The whole green coffee beans may have a lot number assigned 240 for thepurposes of batch control, for instance in compliance with current GoodManufacturing Practices for Dietary Supplements (cGMP), pursuant to 21CFR 111. A predetermined amount of the green coffee beans are loaded 250in the equipment, such as a properly sanitized ribbon mixer. Forexample, in one embodiment, 100 to 300 kilograms of whole green coffeebeans are loaded 250 into a properly sanitized thirty cubic foot ribbonmixer.

The whole green coffee beans are then saturated 260 with an appropriateorganic solvent such as IPA. The saturated beans are then dried 270 in ahygienic manner. The saturated beans may be dried by, for instance,removing them from the ribbon mixer and placing them evenly on cleanpaper-lined trays that are placed in drying racks. The drying Racks maythen be moved into a climate controlled drying room set at, forinstance, 120-130 degrees Fahrenheit, until they are completely dried.This may take approximately twelve to twenty-four hours, for example toreduce the moisture level of the beans from a typical fifteen percent toless than, for example, two percent.

While example sterilization steps have been provided above, any suitablemeans of sterilization may be used. A means of sterilization should besuitable if it sufficiently kills yeast, mold, bacteria, and viralcontamination that may be present on the beans. This is preferably donefor the safety of those consuming the product, and for the purpose ofextending the shelf life of the products of which the green coffee beanswill become a part. The heating and/or drying aspect 270 of the exampleprocess also serves to extend shelf life, as well as to expedite thesteps that follow.

Step 3—Sizing:

The third step, sizing 300, an iterative example of which is illustratedin FIG. 3, may be performed using a coffee-grinding mill. Typicalcoffee-grinding mills tend to generate a great deal of friction andheat. In order to keep the temperature of the beans relatively lowduring this process, for instance under about 130 degrees Fahrenheit,the whole green coffee beans may be ground down to successively smallersizes in a plurality of iterative phases. For example, one embodimentemploys three iterative phases. In Phase One 310, the sterilized anddried beans are passed through a grinder, such as a Modern ProcessEquipment 3 HP Coffee Grinder, reducing the size of the bean to, forinstance, a minus 8-10 mesh screen size. Then in Phase Two 320, thegrinder setting is reduced, for instance from course setting 1 to 3, andthe Phase One material is passed through the grinder, further reducingthe size so that the material will pass through, for instance, a 12-16mesh screen. Next, in Phase Three 330, the grinder setting is reducedagain, for instance from a course setting 3 to a medium setting in therange of 3 to 7, and the Phase Two material is passed through the millagain until all of the material passes through a smaller screen, suchas, for instance, a 20 mesh screen.

Like the other examples provided herein, the above example sizing step300 is just illustrative of the concept, and the invention is notlimited to any of these specific steps unless otherwise stated in theclaims. The point is that grinding or milling green coffee is difficult.To preserve its nutritional integrity during the sizing step 300, thegreen coffee material should not be forced through the mill in a mannerthat would generate excessive heat, for instance heat that would raisethe temperature of the green coffee material above about 130 degreesFahrenheit. For example, instead of filling or stuffing the grinder withgreen coffee material and letting it grind, green coffee material can beintroduced to the grinder at approximately the same rate as the grindergrinds it on a particular setting.

Note that higher temperatures could be used at various steps and stillfall within the scope of the invention, however incremental degradationof the green coffee would likely start to occur according to atime-temperature relationship. For example, the green coffeebeans/material may be able to be subject to temperatures exceeding 130degrees Fahrenheit for several seconds without materially degrading itsnutritional components.

Step 4—Stabilization:

Next, the finely ground whole green coffee bean material may bestabilized 400 as illustrated in FIG. 4. During this step 400 the wholegreen coffee beans that have been ground and classified to predeterminedspecifications as described above may be placed in a properly sanitizedblender. For example, the green coffee bean material may be placed in aPatterson Kelley Twin V sixty-five cubic foot blender that has beensanitized using the three-step process 210, 220, 230 described above. Adrying agent may then be introduced 410 to the green coffee beanmaterial. Suitable drying agents may include, for example, MagnesiumSilicate, Silicon Dioxide, Tricalcium Phosphate, and the like.

In one example embodiment of the stabilization step 400, six hundredkilograms of sterilized and ground green coffee is placed into asterilized Patterson Kelley Twin V sixty-five cubic foot blender. Addedinto the ground green coffee in this example is one to two percent each(by weight) of Magnesium Silicate, Silicon Dioxide, and TricalciumPhosphate through a 12 mesh screen. That combination may then blended ormixed 420 for ten minutes at twenty-four revolution per minute, creatingan example stabilized whole green coffee bean mixture.

While example stabilization steps 410, 420 are described above, anysuitable stabilization procedure may be used. Suitable stabilizationprocedures are those that assist in the long-term preservation of thewhole green coffee bean material, as well as the Chlorogenic acid,essential oils and other phytonutrients naturally present in the greencoffee beans. Suitable stabilization procedures also typically providean anti-caking effect that tends to keep the material from clumping whenin storage, and tends to provide a free-flowing powder that facilitatesthe material being tableted, encapsulated, or otherwise used innutritional products.

Step 5—Testing:

Portions of the stabilized whole green coffee bean mixtures may betested 500, as shown in FIG. 5. Several parameters may be tested orotherwise evaluated in any appropriate order, including, for example,color 510, odor 520, taste 530, appearance 540, moisture levels 550,microbial levels 560, Chlorogenic acid levels 570, caffeine levels 580,and any other suitable testing, for instance as may be required forvarious nutritional applications.

For example, color testing 510 may be accomplished by matching the colorof the material to a light green laboratory control sample. The materialpasses if it is the typical color of ground green coffee. The materialfails if it is not the typical color of ground green coffee. Similarly,odor or smell testing 520 may be accomplished by, for example, matchingthe smell of the material to a laboratory control sample. The materialpasses if it has the typical odor of ground green coffee. The materialfails if it does not have the typical odor of ground green coffee.Likewise, taste testing 530 may be accomplished by, for example,matching the taste of the material to a laboratory control sample. Thematerial passes if it has the typical taste of ground green coffee. Thematerial fails if it does not have the typical taste of ground greencoffee.

Appearance testing 540 may be accomplished by, for example, passing thematerial through a 20 mesh screen. The material may be considered topass if 99% or more passes through the screen.

Moisture level testing 550 may be accomplished by, for example, testingthe moisture level of the material. The material may be considered topass if the moisture level is not more than two percent.

Microbial level testing 560 may be accomplished in various way,including, for example, passing the material if it has a total platecount of not more than 1000, yeast and mold test negative, and coliformtests negative.

Chlorogenic acid level testing 570 may be accomplished using knownmeans.

The material may be considered to pass if, for instance, the Chlorogenicacid levels are not less than two percent.

Caffeine level testing 580 may be accomplished using known means. Whatlevels are considered to pass may change in view of the caffeine leveldesired in the finished product. Unless otherwise specified, thecaffeine level should be the same as naturally occurs in green coffeebeans.

The above testing regimens are examples only and are not limiting. Anysuitable testing may be performed at any stage of the process 1000.

Step 6—Packaging:

The stabilized whole green coffee bean mixtures described above may bepackaged 600 in any of numerous ways, some of which are shown in FIG. 6,and many of which are made possible, or at least especially easier, bythe foregoing steps. The stabilized whole green coffee bean mixtures maybe packaged as oral dosage forms in typical dietary supplement format,added to foods, and/or delivered in a medium for topical, cosmetic use(such as in a cream or ointment, for example). If the stabilized wholegreen coffee bean mixture is to be consumed directly (as a foodadditive, for example), it may be flavored, and thereby serve as adual-purpose product (as a drink-flavoring agent, for example).

For example and not by way of limitation, in certain embodiments theunique and novel stabilized whole green coffee bean mixtures may bepackaged 610 in bulk powder form, may be readily compressed 620 intotablets, may be readily inserted 630 into capsules, or may be mixed 640with another nutritional supplement or product.

Use:

A method of treatment using whole green coffee beans and productscomprising whole green coffee beans has unexpectedly been found todramatically increase focus and concentration in users, and is believeduseful in the treatment of attention deficits. Accordingly, providedherein are novel methods of treatment using green coffee beans andrelated products comprising whole green coffee beans to increase focusand concentration in users, and to treat attention and concentrationdeficits and related disorders, such as attention deficit (AD),attention deficit disorder (ADD), attention deficit hyperactivitydisorder (ADHD), and various related and/or comorbid disorders.

For example and not by way of limitation, the unique and novelstabilized whole green coffee bean mixtures described herein may beadministered to a user, for instance orally, to increase the person'sfocus and concentration. In fact, it has been discovered that certainusers may replace their prescription medications for ADD/ADHD with greencoffee beans and related products comprising whole green coffee beans.Factors that may be considered in determining suitability andappropriate dosage include the user's age, weight, and other medicationsthe user may be taking, as would be apparent to a person of skill in theart when provided with the present disclosure. For example, it initiallyappears that users may be able to replace prescription medications forADD/ADHD with green coffee beans and related products comprising wholegreen coffee beans, such as, for example, the unique and novelstabilized whole green coffee bean mixtures described herein, unless,for instance, the user is also taking anti-depressants.

In one specific example embodiment, a treatment protocol may comprise auser orally consuming the unique and novel stabilized whole green coffeebean mixtures described herein in the form of tablets, capsules, or anyother suitable delivery means, where the dosage contains aboutfifty-five milligrams of caffeine per dosage. In that example protocol,a user may take one dosage in the morning and one in the afternoon fortwo consecutive days. If the user has then not yet experiencedsatisfactory results, the user may continue the treatment with twodosages in the morning and two in the afternoon for two consecutivedays. If the user still has then not yet experienced satisfactoryresults, the user may continue the treatment with three dosages in themorning and three in the afternoon for two consecutive days. It has beenfound that the above example treatment protocol provides satisfactoryresults for the vast majority of users. In the rare instances where thisprotocol is not satisfactory, three dosages may be taken three times aday. It is believed that most users may take three of the above exampledosages four times a day without adverse effect.

Using the example dosages provided in the specific embodiment providedabove, other example treatment protocols may include: one or two dosagestwice a day for persons twelve to sixteen years of age; two dosages inthe morning and one dosage in the early afternoon for persons sixteen toeighteen years of age; and two or three dosages in the morning and twodosages in the early afternoon for persons eighteen years of age andolder.

All the foregoing dosages and treatment regimens are examples only, anddo not limit the scope of the invention except where specificallyclaimed. Any user, especially those allergic or sensitive to caffeine,should consult with their physician before consuming any of thematerials described herein, as with any dietary or energy supplement,and children under the age of eighteen should only consume such productsunder adult supervision. Products such as those disclosed herein shouldlikely be avoided by those who are or may be pregnant or lactating.Dosages may be self-administered by a user or administered by someoneelse to a user.

Consuming whole green coffee beans and related products that comprisewhole green coffee beans provides unexpected synergistic resultscompared to traditional coffee products. For example, in the specificexamples provided above, three dosages comprise about 165 milligrams ofcaffeine, which is approximately equivalent to a traditional cup ofcoffee. But while the primary stimulative effects of a cup of coffeeonly last about twenty to thirty minutes, consuming three of the exampledoses described above provides greatly increased concentration andattention that lasts about four to five hours.

Consuming whole green coffee beans as a solid is believed to provide anatural time-release effect as shown in Figures, taking about fifteenminutes to begin and lasting for several hours, compared to consumingtraditional coffee as a liquid, which causes a rapid up-and-down effect.Consuming products comprising whole green coffee beans, i.e,manufactured from the entire bean, also provides far superior results toconsuming chemicals extracted or isolated from coffee beans, such asextracted Chlorogenic acid. Accordingly, the presently disclosed wholegreen coffee bean products and methods of use provide other unexpectedlysuperior effects in addition to increased concentration and focus,including but not limited to: improved cardiovascular health; increasedresistance to cancer and other diseases; and rapid and sustained weightloss.

Improving Concentration and Focus in Humans Using Whole Green CoffeePowder

Whole Green Coffee Powder, or “WGCP,” in accordance with the principlesof the invention, in moderate doses may improve executive functioningfor sustained attention and working memory without effecting responseinhibition. This method of consuming WGCP may improve focus andconcentration humans.

Whole green coffee powder (WGCP) is a fibrous, naturally occurringendogenous substance and is a nonesterified solid source of caffeine. Itis processed directly from the whole green coffee bean and containschlorogenic acid in its natural form. It is distinct from green coffeeextract because it is made from the whole bean in a specified process(current patent pending), delivers a solid (not from extract) form ofcaffeine in capsules, and is sold commercially as GoBean®. The presenceof naturally occurring green coffee bean nutrients is not available incoffee extract, and the granularity of green coffee powder releasescaffeine and cholinergic acid in an extended delivery. These uniquefeatures may impact attention, arousal, and executive functions inindividuals who use it.

This study investigated the effects of commercially available dietarycaffeine supplement (WGCP) on the ability of neurotypical individuals(ie, without diagnosed ADHD) to exercise executive functions associatedwith sustained attention, spatial working memory, and responseinhibition (ie, impulsivity). These assessed executive functions promotecognitive activity in a way similar to academic study.

To measure the effects of WGCP on core executive functions used instandard academic study, we used the ADHD Core Battery of the CambridgeNeuropsychological Test Automated Battery (CANTAB). This batteryincludes several modules: motor screening (data from this module werenot used in analysis as it tests fine motor speed and is an introductoryexercise to the test battery); rapid visual information processing (RVP,sus

tained attention); stop signal task (SST, response inhibition); andspatial working memory (SWM, working memory). We also investigated thequalitative effects of WGCP via participant self-report. While testsused to study ADHD and treatments thereof, their use here is notintended to suggest that WGCP as discussed herein is used to treat ADHD.Rather use of these test procedures is used only to verify the efficacyof WGCP to improve general focus and concentration among humansgenerally.

Fourteen adults aged 18-25 years, acted as their own controls in threetreatment conditions within a seven-session withdrawal design.Par-ticipants completed the Cambridge Neuropsychological Test AutomatedBattery for attention-deficit/hyperactivity disorder (ADHD) at eachsession. The Side Effects Behavior Monitoring Scale (SEBMS), used toassess stimulant effects in individuals with ADHD, was a secondaryoutcome measure to assess adverse events associated with caffeine intakedelivered by capsule. Self-report of qualitative effects was collected.

Results indicated that moderate doses of WGCP significantly improvedsustained attention (vs placebo and low dose) and working memory (vs lowdose only) but had no effect on response inhibition. Low doses of WGCPshowed decreased sustained attention. Fifty percent of subjects reportedpositive subjective improvement in well-being. No side effects werereported.

The study explored the following primary research questions:

1. What are the effects of WGCP compared with placebo on sustainedattention, response inhibition, and spatial working memory?

2. How do subjects qualitatively describe the effects of WGCP onaffective presentation in daily activity?

Method

This study used a small N approach to acquire preliminary information onthe effects of WGCP. Small N studies are limited in controllingvariability, but repeated measures allow them to be useful especiallywhen studying novel treatments. The power of well-designed repeatedmeasures designs is evident in that with 10 participants, receiving onlyfive measurements across the study, power to detect significantdifferences within subjects across conditions is quite good (power=0.89using Cohen's f) when a large effect size (f=0.40; ˜d=0.80), moderatetest-retest reliability (correlation) between repeated measurements(r=0.60), and a typical Type 1 error rate (0.05) are assumed. A largeeffect size is entirely reasonable to expect in repeated measuresdesigns and the test-retest correlation is likely to actually be larger,possibly as high as the reported test-retest reliability of the test(0.80) which would drive power even higher (0.99). Readers interested instatistical analyses for this study may contact the first author forsyntax.

Assumptions of study design. Referenced in previous studies withcaffeine delivery, the following documented characteristics of caffeineare assumed for the use of WGCP in this study: (1) washout of WGCPeffect will occur rapidly similar to caffeine washout in other deliverysystems (ie, over the period of several hours); (2) dosing may beabruptly terminated without adverse side effects; (3) WGCP effects atmoderate dose are not dependent on gradual increase from low dose, thatis, subjects do not need gradual exposure to caffeine from low dose (inall cases, nevertheless, low dose preceded moderate dose); (4) onset ofWGCP effect is established within one hour as is typical of caffeineproducts used in previous studies. Essentially, given no evidence to thecontrary, WGCP will produce caffeine effects similar to other deliverysystems.

Procedures.

We used a repeated measures withdrawal of treatment design to examinethe differential effects of a commercially available dietary supplement(GoBean®) and placebo in neurotypical college-age adults, aged 18 to 25years. The design removes variability through improved experimentalcontrol of treatment conditions. A withdrawal of treatment designallowed multiple observations of a small number of subjects (compared torandomized clinical trial designs that use few observations of manysubjects). The design alternated treatment and no-treatment conditionsacross days within single subjects to provide sensitive examination ofdose effects. Collection of time-series data permitted the assessment ofongoing treatment-related changes across each presentation of thedependent variable.

The trial is initiated in the baseline (BL) phase of an experimentalmanipulation of variables. The placebo (A) phase is alternated with theexperimental phases. In this study, B1 was the first dose of the activecompound (ie, WGCP), and B2 the second dose of the active compound. ThePhase A is an intermediary phase between BL and active compound (B1 andB2) and controls for an expectancy of improvement associated with mereingestion of a capsule as part of a trial (ie, placebo effect). Wemaintained the rule central to experimental manipulation ofvariables—only one variable was changed at a time. This allowed foropportunity to distinguish between expectancy (ie, placebo) and WGCPeffects.

After a verbal inquiry to confirm overnight caffeine abstinence,subjects received three identical capsules at each session with varyingnumber of capsules containing WGCP. Each capsule contained placebo or444.8 mg WGCP proprietary blend (55 mg caffeine as per GoBean® packagelabel). Capsules were administered orally once each day in the presenceof the study coordinator and one hour prior to CANTAB. Supplements weresupplied in labeled plastic containers with study and subjectrandomization information (ie, study session number and subject codedidentification), and sponsor on the label. In Phase A (placebo), all thethree capsules contained an inert substance (ie, corn starch); in PhaseB1, subjects received one placebo capsule and two WGCP capsules (889.6mg); and in Phase B2, subjects received three capsules each with thesame equivalent dose of WGCP (1334.4 mg). Package label instructions forusing WGCP include a three-capsule dose. The study ran seven months(February-August 2013). Study visits were separated by at least one daywith an average 3.66 days between each dose administration, and a rangeof 1-15 days. Six subjects were administered GoBean and the CANTABbefore noon, and eight subjects were administered GoBean and the CANTABbetween noon and 6:00 pm.

The order of the dose was not randomized since the concern was not ifdose improves performance but only whether WGCP improved performance. Tovarying degrees across subjects, this also permitted us to detectresidual effects of withdrawal. Because the safety of subjects is alwaysparamount and despite the assumption that WGCP does not require gradualintroduction, we moved from low to moderate dose to ensure that thesubjects did not start with a dose to which they may be overlysensitive.

Because the order of presentation of treatment was defined a priori,placebo was counterbalanced across two orders of treatment to maintainthe double-blind requirement; experimenters were unaware of the order oftreatments. The counterbalanced treatment orders are indicated below:

I. BL-A-B1-A-B2-A-B2

II. BL-B1-A-B2-A-B2-A

We assessed for subjects' medications, recreational drugs, or caffeineconsumed through diet or other supplements prior to each administrationand relied on subjects' accurate representation through verbal query.

The study focused on acute administration of WGCP, that is, subjectswere provided doses of caffeine within a short period. This waspracticed because similar studies with chronic caffeine use showeddiminished sustained attention and working memory compared to those whoabruptly terminated chronic caffeine use.

Eligible subjects were randomly assigned to orders I and II; eightsubjects received presentation I and six subjects received presentationII. Each subject arrived at the clinic at the same time in eachexperimental phase and the assigned times did not differ across placeboand active WGCP days. As an example, if Subject 1 arrived for her BLvisit at 8 am, she came to subsequent WGCP active and placebo visits at8 am. After arrival, subjects were given the randomized dose of WGCPand/or placebo. In one hour, subjects were presented the CANTAB whichtook approximately 30 minutes to complete and was administered at thesame time of day, replicating BL conditions. The CANTAB was presented ina quiet, moderately lit room located in the library of a localuniversity campus or in a similar room in a hospital setting; eachsubject completed the CANTAB in the same room in which it was initiated.Sessions were separated by at least 1 day to completely eliminatecarryover effects as WGCP has duration of action of 4-6 hours (as perpackage label). After CANTAB administration, subjects verbally completedthe Side Effects Behavior Monitoring Scale (SEBMS) with the studycoordinator.

Statistical analyses of CANTAB subtests. Sustained attention wasmeasured using the discriminability parameter of the Rapid VisualProcessing subtest. Response inhibition was measured using stop signalreaction time from the Stop Signal subtest. Spatial working memory wasmeasured using total errors from the Spatial Working Memory subtest. Foreach dependent variable, a generalized estimating equations (GEE) modelwas computed with Treatment (placebo, low dose, and moderate dose) asfixed-factor predictors and the dependent variable as the responsevariable. GEE is advantageous in that it flexibly accounts for repeatedmeasurements with each participant permitting missing data andexplicitly modeling relationships between repeated measures conditions.Alternative covariance structures were examined. Results are based onautoregressive structure. GEE analysis assumed a Poisson distributionwith log-linear link for ordinal/count data and a normal distributionwith linear link for continuous data. The analyses estimate treatmentcondition effects using all available conditions. They are nottechnically averaged but rather using GEE models with all availabledata, the estimate is generated based on data from each instance of eachtreatment condition. Preliminary analyses examined order effects.However, there were no significant main effects or interactions withorder. Therefore, results are presented without order included as anindependent variable. Further

more, given that the low- and moderate-dose conditions were in oppositedirections relative to placebo, it is highly unlikely that any ordereffects influence the pattern of results.

Measures

The CANTAB ADHD Battery was the primary outcome measure. It has beendemonstrated to detect neuropsychological effects with selectivity andsensitivity, allows ready interpretation of the effects, and it has avariety of applications in psychology, neuropsychology, and medicine.

The Motor Screening Task is administered at the beginning of the CANTABand assesses whether a subject can respond to the requirements of theother tasks in the battery; it confirms appropriate visual, movement,and comprehension abilities. Rapid Visual Processing of Information(RVP) is a test of sustained attention and is similar to the commonlyused Continuous Performance Test; it is a sensitive measure of generalcognitive performance. The Stop Signal Task (SST) is a common assessmenttask used to assess response inhibition; it estimates an individual'sreaction time and gives a measure of how well an individual can inhibitresponses and resist the tendency to respond automatically. SpatialWorking Memory (SWM) is a test of the participant's ability to useworking memory by retaining spatial information, remembering items, andmanipulated them in space; this test measures global executivedysfunction.

The CANTAB subtests were administered once in each session. Publishedstudies demonstrated that parallel versions of the CANTAB allow repeatedmeasures and that the CANTAB shows very small practice effects overrepeated measures.

Qualitative descriptions and adverse events were assessed in eachsession. Side effects were assessed using the SEBMS adverse eventschecklist The SEBMS uses the Clinical Global Impressions-Severity(CGI-S) anchored scale (1=normal, 2=borderline, 3=mild, 4=moderate,5=marked, 6=severe, and 7=most extreme).22,23 Subjects completed theSEBMS at the end of each session to track change in behavior. Allratings were based on participants' subjective experience of the1.5-hour period and on subjective reports between sessions. An adverseevent was defined as any untoward medical or physical occurrence in asubject administered WGCP during the course of the study. Participantswere probed as to the presence of side effects including heart functionanomalies.

The ADHD Rating Scale (ADHD-RS) is an 18-item scale used to rule outsymptomatic attentional difficulties. It was administered at BLcoinciding with assessment of working memory and response inhibition asmeasured by the CAN

TAB. It was used to screen for the presence of ADHD. Scores over 32 aregenerally considered symptomatic threshold.

Drug screening was conducted by inviting the participants to give verbalself-report of use.

Subjects

Inclusion criteria. To be eligible for inclusion, participants metcriteria at initial screening and BL, in which (a) a written consent wassigned by the participant; (b) the participant was aged 18-25 years; (c)females of childbearing age had a negative response to a verbal inquiryfor pregnancy and were not at risk for becoming pregnant; (d)participants completed an ADHD rating scale; (e) participants had aminimum level of intellectual functioning (determined by theinvestigator, all participants were or had been enrolled in collegecourses); (f) symptom criteria for a comorbid mental health conditionthat could affect safety or tolerability of medication, or interferewith the participant's participation in the study were not in evidence;(g) blood pressure measurements were within the 95th percentile for ageand gender at screening; and (h) participants were able to comply withthe requirements of the study protocol.

Exclusion criteria. At screening or BL, eligibility was declined if theparticipant (a) had a current, controlled, or uncontrolled comorbidpsychiatric diagnosis with significant symptoms, that, in the opinion ofthe study investigator, contraindicated treatment, or assessment; (b)was suspected of substance abuse or dependence disorder within the past12 months in accordance with DSM-IV-TR criteria; (c) admitted to the useof prescription or illegal substance; (d) had a history of seizuresduring the last two years, a severe tic disorder, and a currentdiagnosis or family history of Tourette's syndrome; (e) had a conductdisorder; (f) had taken an investigational product within 30 days priorto screening, or participated in any other research study during thetrial; (g) had clinically significant blood pressure abnormalities atBL; (h) had a known history of structural cardiac abnormality; (i) had aconcurrent chronic or acute medical illness that would prohibit theparticipant from completing the study or would not be in the bestinterest of the participant; (j) taking any medications that areexcluded, have other central nervous system (CNS) dysfunction, or effectperformance, such as sedating antihistamines and decongestantsympathomimetics (bronchodilators were not exclusionary); and (k) thefemale subject was pregnant or lactating.

Subject confidentiality and consent. Subjects were interviewed by thestudy investigator or study coordinator. Subjects signed the consentform during the interview period and consents were obtained at least oneweek prior to the start of the study period. The hospital InstitutionalReview Board (IRB) approved the study protocol and informed consentprocedures.

Results

A total of 16 adults not diagnosed with ADHD or other psychiatricconditions were screened for participation; 14 enrolled in the study(see Table 1). This study population was useful because of participants'ongoing engagement with academic tasks. Academic studies requiresufficient working memory and the ability to delay a response tocompeting activities (eg, participating with friends) to completerequired academic work.

TABLE 1 Subject Demographics Order 1 Order 2 (Placebo First) (Placebo2^(nd)) P-Value n 8 6 Male (n, %) 2 (25.0%) 2 (33.3%) .594 Whitenon-Hispanic (n) 8 6 Age (M, SD) 21.25 (1.49) 21.83 (1.94) .662 Note:non-parametric statistics ((Mann-Whitney U and Fisher's exact test) werecomputed.

The study generated information on the effects of WGCP on: a) sustainedattention (RVP), b) response inhibition (SST), c) spatial working memory(SWM), and d) qualitative descriptions of the effects of WGCP amongyoung adults.

Results indicated a significant overall treatment effect for sustainedattention (Rapid Visual Processing—total misses) (c2(2)=58.62, P 0.001).Low-dose WGCP resulted in significantly worse sustained attention thanplacebo in significantly better sustained attention than placebo(c2(1)=5.22, P=0.022). Significant differences were also noted inworking memory (c2(1)=26.36, P=0.001). Spatial working memory errorswere highest in the low-dose WGCP and lowest in the moderate-dose WGCP.Placebo fell in-between these values but pairwise comparisons were notstatistically significant (low dose vs placebo c2(1)=1.11, P=0.293 andmoderate dose vs placebo c2(1)=2.15, P=0.142). No significantdifferences were observed for response inhibition (impulsivity) (overallP=0.0579; see Table 2).

TABLE 2 Treatment effects on CANTAB WGCP WGCP WGCP LOW MODERATE WGCP LOWMODERATE CANTAB χ²- P- PLACEBO DOSE DOSE MEAN DOSE VS. DOSE VS.PARAMETER TASK VALUE VALUE MEAN (SE) MEAN (SE) (SE) PLACEBO (d) PLACEBO(d) Sustained RVP 58.62 p .001 3.24 (0.58) 4.43 (0.69) 2.46 (0.49) .29−.23 attention Response SST 1.09 p = .579 142.8 (6.5)  145.3 (6.0) 139.0 (5.0)  −.06 .10 inhibition Spatial working SWM 26.36 p .001 4.62(1.39) 6.00 (1.66) 3.86 (1.38) .14 .09 memory Abbrevations: RVP, RapidVisual Information Processing—Total missed targets (lower scoresindicate better performance); SST, Stop Signal Task—reaction time lasthalf of task (lower scores indicate faster performance); SWM, SpatialWorking Memory Task—total errors (lower scores indicate betterperformance).

The mean ADHD rating scale score was 26.4 and nonsymptomatic for ADHD.Subjects did not differ on measures of attention dysfunction (see Table3).

TABLE 3 ADHD rating scale measures of attention dysfunction. MEAN SCOREWGCP LOW WGCP TARGET SYMPTOMS BASELINE PLACEBO DOSE MODERATE DOSE X² (p)Overactivity; motor 1.29 1.36 1.34 1.34 2.89 (.409) restlessnessImpulsiveness; 1.33 1.26 1.27 1.26 8.58 (.035) acting without thinkingDistractibility; 1.57 1.54 1.44 1.60 3.70 (.296) sustaining attention totasks Task completion; 1.17 1.11 1.09 1.13 3.00 (.392) finishing tasksBeing on 1.14 1.14 1.14 1.14 — time/Accepting limits Following 1.13 1 11 — Instructions Frustration tolerance; 1.21 1.21 1.21 1.21 —appropriately expresses frustration Ability to calm self 1.43 1.41 1.631.36 2.39 (.495) when excited Non-family/Peer 1.07 1.07 1.07 1.07 —relations Family/Close 1 1 1 1 — relations Notes: GEE analysis assumingpoisson distribution with log-linear link for ordinal/count data. Waldc2 degrees of freedom equals 3. In many cases, the counts were ofextremely low variability (almost entirely scores of 1). Therefore, teststatistics could not be computed or should be seen only as descriptiveof the general pattern.

Qualitative results. At the end of each session, participants gavesubjective accounts of their experience from the time they ingestedcapsules until the completion of the CANTAB (approximately one and ahalf hours). In addition, they described reactions from the previousadministration of WGCP. The SEBMS probed whether any of the 20 specificside effect reactions to stimulant medication were present. Participantsshowed no adverse events (Table 4). When probed whether they discernedreceiving an active dose or placebo, seven participants were unable toidentify whether they received active ingredient or placebo; sevenparticipants accurately discerned that they had received WGCP moderatedose but not the low dose.

Participants reported qualitative reactions to the moderate dose thatare best defined in three areas: (1) increased efficiency on tasks, (2)enhanced ability to stay on task, and (3) a feeling of well-being. Forexample, Participant 14 stated that she felt “extra focused on the workI did in the morning.” Participant 10, a college student, stated thatshe “felt really good and focused even though I have a lot to do today.”Participant 8 reported, “I got more done in an hour today compared toyesterday.” Others reported “feeling good” and the absence of feelingsof malaise or intrusive emotions.

Other qualitative reports show that acute exposure to WGCP, asadministered in this study, resulted in increased alertness, improvedconcentration, decreased fatigue, and significantly increased feelingsof contentedness and satisfaction.

Side effects are summarized in Table 4. No significant side effects arereported. Side effect ratings on the CGI-S are all rated as normal ornot at all present.

DISCUSSION

This study confirmed effects of improved sustained attention and, to alesser extent, spatial working memory with WGCP intake. Sustainedattention showed improvement with moderate-dose WGCP, includingseparation from placebo and low-dose WGCP. The results for workingmemory were similar in pattern but quantitatively weaker, withmoderate-dose WGCP showing improved working memory relative to low dosebut not versus placebo. Results indicated a negative effect on sustainedattention and working memory for low-dose WGCP (two capsules) contrastedwith the strong positive effect for moderate-dose WGCP (three capsules).The positive effect of moderate-dose WCGP on sustained attention wasmodest in size (d=−0.23). Although not dramatic, this effect may beclinically meaningful and may be noticeable to individuals when workingin contexts that require substantial sustained attention. The inhibitoryeffect at low dose is difficult to explain. At a low dose, WGCB mayinhibit fatigue but it may not deliver enough caffeine to produce thecognitive effects that moderate doses do. If low dose was simply anon-effect, then placebo and low dose should be similar. They were notsimilar, however; low dose inhibited response. The inhibitory functionof low dose may be evidence of a side effect, such as minor agitation,that occurs at smaller doses of WGCP. Individual variance of responsemay also explain these effects.

TABLE 4 Side effects behavior monitoring scale. MEAN SCORE WGCP LOW WGCPSIDE EFFECT BASE LINE PLACEBO DOSE MODERATE DOSE X²(P) Insomnia ortrouble 1.43 1 1.14 1 6.00 (.112) sleeping Nightmares 1.07 1 1 1 1.08(.299) Stares a lot or 1.43 1.21 1.21 1.14 5.68 (.128) daydreams Talksless with others 1.21 1.02 1.07 1 3.64 (.303) Uninterested in others1.14 1.02 1 1 4.78 (.187) Decreased appetite 1.29 1.05 1 1 2.34 (.504)Irritable 1.43 1.05 1.14 1.04 7.10 (.069) Stomachaches 1.29 1.02 1.211.04 3.45 (.328) Headaches 1.57 1.17 1.29 1.14 6.87 (.076) Drowsiness1.71 1.69 1.57 1.36 7.91 (.048) Sad/Unhappy 1.21 1.02 1 1.07 3.52 (.318)Prone to crying/Easily 1.21 1 1 1 2.07 (.151) upset Anxious/Worried 1.431.02 1.07 1.11 5.17 (.160) Perseveration (verbal 1.14 1 1 1 2.33 (.127)or behavioral) Bites/Picks skin or 1.36 1.02 1.07 1 7.77 (.051)fingernails Euphoric/Unusually 1.21 1 1 1.07 3.82 (.148) happy/ManiaDizziness 1.14 1.10 1.14 1.14 2.74 (.433) Tics or nervous 1.07 1.07 1.071 2.67 (.446) movements Overfocused (tunes 1.21 1.19 1.21 1.18 0.04(.998) others out) Hallucinosis 1 1 1 1 — Flat affect/Emotional 1 1.02 11 1.08 (.299) blunting Dry mouth 1 1 1.07 1.04 1.08 (.299) Numbness ortingling in 1.14 1.05 1 1 2.67 (.446) extremities Notes: Wald c2 degreesof freedom equals 3. In many cases, the counts were of extremely lowvariability (almost entirely scores of 1). Therefore, test statisticscould not be computed or should be seen only as descriptive of thegeneral pattern. 1 = normal, 2 = borderline, 3 = mild, 4 = moderate, 5 =marked, 6 = severe, and 7 = most extreme.

WGCP at a moderate dose tended to be associated with a qualitativelypositive affective response. In interview, subjects reported a sense ofwell-being and an ability to initiate tasks more easily. For example,use of WGCP decreased ratings of sleepy, tired, drowsy, “half awake”,lazy, and sluggish. Subjects reported that they experienced an overallsense of contentedness and that they felt more at ease, relaxed, andsatisfied. The substance induced more reportedly energetic feelings aswell as heightened friendliness and sociability. In addition, evidencefrom previous studies14 and common knowledge indicate a deleteriouseffect (eg, jitteriness or nervousness) of chronic caffeine ingestion.However, subjects in this study did not report these effects with WGCP.Additionally, inquiries regarding heart palpitations, rapid rate, orother cardiac function anomalies were not reported in probed interview.

It is an interesting finding that moderate-dose WGCP improved spatialworking memory relative to low dose. Working memory is a complexfunction that involves the ability to manipulate and control informationsuch that the information is both symbolically stored and processed inverbal and spatial forms. Neurologically, the information processed inworking memory is stored throughout the brain depending on the nature ofthe eliciting information.25 Caffeine effects, functionally altering theadenosine receptors, may impact the wide variety of neural pathwaysassociated with working memory and may require higher WGCPconcentration.

The finding that WGCP did not affect response inhibition is expected.Inhibitive functions are typically considered to be prefrontal,neurological events. Response inhibition is the ability to keepinterfering information away from focused attention. It, too, is complexand may be outside the effects of neural pathways associated withcaffeine effects as delivered by WGCP.

The nature and mode of delivery of caffeine may influence its effect onexecutive performance. According to the packaging label of GoBean®, thedelivery of caffeine using WGCP provides the “natural caffeine that isdeep within the fiber of the bean.” Caffeine extracts rather than“natural caffeine” are typically used in commercially sold liquidproducts. The study did not compare WGCP with other caffeine deliverysystems. It is possible that the effects on sustained attention and thereported positive qualitative effects may be a function of both caffeineand the nutrients that are not available in extracts. In addition,effects of WGCP may also be due to the mode of ingestion. The method ofdelivery—taking a capsule vs drinking a liquid—may represent a distinctdifference in caffeine effects.24 Although the features unique to WGCPare interesting, further study is required as this investigation doesnot provide information on the addition of nutrients in caffeine or onthe delivery provided by WGCP; further investigation is required.

Research is certainly required to fully appreciate the different effectson attention and behavior associated with WGCP. Many studies of theeffects of caffeine were conducted more than a decade ago, however, andthese relied on extract rather than on caffeine occurring in its naturalstate. Given the variety of availability of caffeine products from dietsupplements to energy drinks, study of new delivery systems of the rawbean is warranted especially as this relates to adverse events.

A consideration of the study is the carryover of WGCP effects from onephase of the manipulation to the other. This problem was handled in thecounterbalanced repeated measures design of the study. In futurestudies, however, length of phases may be varied to determine WGCPlatency effects (ie, onset of action of WGCP), and residual effects (ie,persisting WGCP effects during placebo phase) after active WGCP isterminated. Both latency and residual effects must be investigated toengage larger N trials to ensure safety of subjects and to determinetimeliness of active WGCP exposure.

An interesting finding is that seven subjects (50%) were unable todiscern between placebo and active WGCP, and the remaining subjectsdiscerned only the moderate WGCP dose but not the low dose. Many factorsimpact whether a person recognizes changes in personal physiology;factors such as reaction sensitivity, ability to self-observe bodilychanges, the opportunity to note changes (eg, a busy day full ofattention occupying activity impairs self-monitoring vs a relativelycalm, predictable day that allows it) and the same may explain thisphenomenon.

The above steps are set forth to illustrate general concepts. Numerousother steps, and combinations and permutations thereof, arecontemplated, and are inherently and necessarily disclosed to persons ofordinary skill in the art by the foregoing description.

Although exemplary embodiments and applications of the invention havebeen described herein, there is no intention that the invention belimited to these exemplary embodiments and applications or to the mannerin which the exemplary embodiments and applications operate or aredescribed herein. Indeed, many variations and modifications to theexemplary embodiments are possible as long as the resulting methods andproducts fall within the scope of one of the following claims or itsequivalent.

Whereas, the present invention has been described in relation to thedrawings attached hereto, it should be understood that other and furthermodifications, apart from those shown or suggested herein, may be madewithin the spirit and scope of this invention. Descriptions of theembodiments shown in the drawings should not be construed as limiting ordefining the ordinary and plain meanings of the terms of the claimsunless such is explicitly indicated.

As such, those skilled in the art will appreciate that the conception,upon which this disclosure is based, may readily be utilized as a basisfor the designing of other structures, methods and systems for carryingout the several purposes of the present invention. It is important,therefore, that the claims be regarded as including such equivalentconstructions insofar as they do not depart from the spirit and scope ofthe present invention.

1. A method of increasing the focus and concentration of a usercomprising the steps of: the user orally ingesting a whole green coffeebean powder in an amount effective to treat the user, the stabilizedunroasted whole green coffee bean powder comprising: a material derivedfrom whole green coffee beans in their fresh green unroasted state withnaturally-occurring levels of phytonutrients, by sterilizing theunroasted whole green coffee beans and grinding the whole green coffeebeans to a size capable of passing a 20 mesh screen; and at least onestabilizer; wherein the material has not been exposed to temperaturesabove 130 degrees Fahrenheit for more than several seconds; and, whereinthe moisture content of the stabilized unroasted whole green coffee beanmixture is less than about two percent.
 2. A method of increasing theconcentration of and focusing the attention of a user for at least fourhours without ingesting more than about 165 milligrams of caffeine,comprising the steps of: the user orally ingesting a product comprisinga stabilized unroasted whole green coffee bean mixture in an amounteffective to treat the user, the stabilized unroasted whole green coffeebean mixture comprising: entire whole green coffee beans having beenobtained by removal of pulp and skin from coffee berries, sterile, intheir fresh green unroasted state with naturally-occurring levels ofphytonutrients, ground to pass through a 20 mesh screen; and at leastone stabilizer; wherein the stabilized unroasted whole green coffee beanmixture has not been exposed to temperatures above 130 degreesFahrenheit for more than several seconds.